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CTRI Number  CTRI/2026/02/104108 [Registered on: 17/02/2026] Trial Registered Prospectively
Last Modified On: 17/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Calf Muscle Mobilization device to improve pain relief and functional mobility 
Scientific Title of Study   Design and validation of calf muscle mobilization device to improve pain relief and functional mobility 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dhara Kotadiya 
Designation  Post Graduate student 
Affiliation  School of Physiotherapy, RK University 
Address  School Of Physiotherapy - RK University Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot

Rajkot
GUJARAT
360020
India 
Phone  9328553577  
Fax    
Email  dkothaidya874@rku.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Priyanshu V Rathod 
Designation  Professor and Dean Faculty of Medicine  
Affiliation  School of Physiotherapy, RK University 
Address  School Of Physiotherapy - RK University Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot

Rajkot
GUJARAT
360020
India 
Phone  9426803108  
Fax    
Email  priyanshu.rathod@rku.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Priyanshu V Rathod 
Designation  Professor and Dean Faculty of Medicine  
Affiliation  School of Physiotherapy, RK University 
Address  School Of Physiotherapy - RK University Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot

Rajkot
GUJARAT
360020
India 
Phone  9426803108  
Fax    
Email  priyanshu.rathod@rku.ac.in  
 
Source of Monetary or Material Support  
School of Physiotherapy, RK University, Bhavnagar Highway, Kasturbadham, Rajkot - 360020, Gujarat, India. 
 
Primary Sponsor  
Name  School of Physiotherapy- RK University 
Address  Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India.  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Dhara Kotadiya   School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot- 360020, Gujrat, India.  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dhara Kotadiya  RK Physiotherapy Rehabilitation and Research Center  Physiotherapy Department, Room no.1, opposite Meghani rang bhavan, Bhaktinagar circle, Rajkot-360002, Gujarat, India Rajkot GUJARAT
Rajkot
GUJARAT 
9328553577

dkothaidya874@rku.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
School of Physiotherapy, RK University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  With and Without Calf pain, spasm, and tightness 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Effect of Calf Muscle Mobilization Device on Healthy Individuals With or Without Calf Pain.  The innovative device has been developed based on pneumatic compression and relaxation, a hand massage like movement with two cuff-like structure to mobilise the calf muscles from distal to proximal, As inflation and deflation time of each cuff is 7 and 8 seconds device will apply for total 8 minutes and after immediately post assessment will taken. After 2 weeks same procedures will taken and assessed.  
Comparator Agent  Effect of manual massage and stretching techniques on patient.  Therapist will give manual massage and stretching to the patient .manual massage will given for 8 minutes and stretching will apply for 15 seconds hold, 3 repetition. After 2 weeks same procedures will taken and assessed.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Written informed consent to participate in the study voluntarily.
2) Person with or without calf pain
 
 
ExclusionCriteria 
Details  1)Mentally retarded patients
2)Open wounds  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)ankle dorsiflexion and plantarflexion range of motion (degrees) following intervention using the Calf Muscle Mobilization Device.

 
Baseline (Pre-intervention) and Immediately Post-intervention,2 weeks after baseline 
 
Secondary Outcome  
Outcome  TimePoints 
1)VAS scale for pain assessment
2)single leg stance test performance (eyes open & eyes closed)
3)single leg heel raise test performance (number of repetitions in 30 seconds)
4)QUEST 2.0 For user sefty,satisfaction & comfort
5)Timed up & go test for balance improvement
 
Baseline (Pre-intervention) & Immediately Post-intervention,2 weeks after baseline 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/03/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Calf muscle dysfunction, including pain, tightness, spasm, and venous congestion, is a frequent clinical problem affecting individuals across sedentary and physically active populations, often resulting in discomfort and impaired functional mobility. Conventional management approaches such as manual therapy, stretching, and compression modalities, while widely used, are commonly limited by therapist dependence, inconsistent application, and lack of standardization. To address these limitations, a self-operated device for calf muscle mobilization was designed and developed to deliver controlled, graded distal-to-proximal compression and soft tissue mobilization, simulating the physiological action of the calf muscle pump.

This study aimed to design and validate the device and to evaluate its clinical effects on pain, muscle flexibility, balance, and functional performance. The device was engineered to produce standardized, repeatable dual mode (mild and moderate comression) compression–relaxation cycles (7+8 seconds) with adjustable intensity and treatment duration, emphasizing safety, comfort, and reproducibility. The evaluation will be done before and after the 5-10 minutes of device for calf muscle mobilization, including pain intensity assessed by the Visual Analogue Scale (VAS), ankle dorsiflexion range of motion (ROM) as an indicator of calf muscle flexibility, functional mobility measured through the Timed Up and Go (TUG) test, static balance assessed by the Single Leg Stand Test, and calf muscle endurance evaluated using the Single Leg Heel Raise Test. User satisfaction and perceived usability were assessed using the QUEST 2.0 questionnaire. Device reliability was also examined.

The device functions by applying rhythmic, graded compression in a distal-to-proximal sequence, aiming to facilitate soft tissue mobilization, reduce muscle discomfort and tightness, and support venous return. The selected outcome measures (VAS, ankle dorsiflexion ROM, TUG, Single Leg Stand Test, Single Leg Heel Raise Test, and QUEST 2.0) enabled objective assessment of pain, flexibility, balance, muscular endurance, functional mobility, and user satisfaction following device use. This framework supports systematic evaluation of the device’s therapeutic utility and clinical applicability.

 
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